Difficult AirwaySEALIONNCT06683599
SEALion: Study on Supplemental Oxygenation Via Nasal Cannula for Young Children During Intubation
A study testing Apneic oxygenation in people with Difficult Airway and Difficult Airway Intubation, run by Vinícius C Quintão, MD, MSc, PhD at 4 sites in 4 countries.
Trial summary
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Read more about this study
- Who is it for?
- Ages 1 minute to 52 weeks
- Conditions the study is for
- Difficult Airway, Difficult Airway Intubation, Neonate
- What is being tested?
- Apneic oxygenation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 10 Dec 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 minute to 52 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.
- Neonates and infants up to 52 weeks post-conceptual age.
- Written informed consent provided by legal guardians prior to the intervention.
Who cannot join
- Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
- Requirement for an alternative technique to direct laryngoscopy to secure the airway.
- Specific conditions, such as congenital heart disease requiring FiO₂ < 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.
Trial locations and contacts
4 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 4 countries
Australia1 site, 1 recruiting
- Recruiting
Perth Children's Hospital
Perth, Western Australia, 6009
Britta S von Ungern-Sternberg, MD, PhD, 08 64564806, Britta.Regli-VonUngern@health.wa.gov.au
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clinicas HCFMUSP
São Paulo, São Paulo, 05403000
Vinicius C Quintao, MD, MSc, PhD, +55 11 97127-3950, vinicius.quintao@hc.fm.usp.br
Canada1 site, 1 recruiting
- Recruiting
British Columbia Children's Hospital
Vancouver, British Columbia
Simon Whyte, MD, 604-875-2711, swhyte@bcchr.ca
Sweden1 site, 1 recruiting
- Recruiting
Uppsala University Hospital
Uppsala
Peter Frykholm, MD, peter.frykholm@uu.se
About this study
Official title: SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ <80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time.
This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.
Read the detailed description
Eligible children will undergo preparation for intubation following the local Standard Operating Procedures (SOPs) of the pediatric anesthesia departments. Mandatory monitoring includes pulse oximetry (SpO2), heart rate (HR), and non-invasive blood pressure (NIBP).
Anesthesia Induction:
Where feasible, all children enrolled in this protocol will be pre-oxygenated for one minute prior to induction of anesthesia using a face mask with FiO2 1.0 and a flow rate of 6-10 L/min. Anesthesia induction for tracheal intubation will involve a combination of sedative or hypnotic drugs, opioids, and a non-depolarizing muscle relaxant.
Required Medications (per protocol):
Neuromuscular Blocking Agent (NMBA): One of the following-Rocuronium 0.5-1 mg/kg, Cis-Atracurium 0.2-0.5 mg/kg, Atracurium 0.5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2-0.3 mg/kg, or Succinylcholine 2 mg/kg.
Hypnotic Agent: One or more of the following-Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, or Sevoflurane up to 8%.
Optional Medications: An opioid and/or anticholinergic may be administered at the anesthetist's discretion.
Pre-Intubation Preparation:
Following induction of anesthesia and administration of an NMBA, bag-mask ventilation with FiO2 1.0 (flow rate of 6-10 L/min) will be performed for 60 seconds until apnea occurs. To facilitate airway management, complete neuromuscular blockade will be confirmed using train-of-four (TOF) monitoring. Oxygen administration, laryngoscopy, and tracheal intubation will follow.
Intubation Procedure:
Oxygen administration during intubation is mandatory for all participants and will be randomized as follows:
Apneic Oxygenation: Oxygen will be administered at 1 L/kg/min via a conventional nasal cannula. Laryngoscopy and tracheal intubation will proceed following apneic oxygenation.
Standard Care: No apneic oxygenation will be administered. After induction, laryngoscopy and tracheal intubation will proceed without additional oxygen support.
Tube Selection:
For premature neonates under 1 kg, an uncuffed tube with an internal diameter (ID) of 2.5 will be used.
For premature neonates and newborns between 1 kg and 3.0 kg, an uncuffed tube with ID 3.0 will be used.
For babies over 3.0 kg up to 8 months, a cuffed tube with ID 3.0 or an uncuffed tube with ID 3.5 will be used.
For infants aged 8 to 12 months, a cuffed tube with ID 3.5 or an uncuffed tube with ID 4.0 will be used.
Oxygen delivery will follow the assigned randomization group, either via conventional nasal cannula (apneic oxygenation) or standard care.
Laryngoscope Blade Selection:
For children weighing less than 1 kg, a Miller or Macintosh blade, size No. 0, will be used. In cases of unexpected difficult intubation, the difficult airway algorithm will be applied. After an unsuccessful first intubation attempt with the assigned flow rate, clinical judgment will guide the intubating physician on whether to repeat the attempt with the same flow rate or to modify the flow rate, blade size, or type of laryngoscope. A maximum of four intubation attempts will be allowed, with the final attempt performed by the most experienced physician present. Additional tools, such as a stylet or bougie, may be used at any stage. If intubation remains unsuccessful, the difficult airway algorithm will be applied, and a supraglottic airway (SGA) device will be inserted.
- Conditions
- Difficult Airway, Difficult Airway Intubation, Neonate
- Being tested
- Apneic oxygenation
- Keywords
- Difficult intubation, Apneic oxygenation, Neonate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apneic oxygenationProcedure or surgery
1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation. |
| Apneic oxygenation | Experimental | 1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1. Receives: Procedure: Apneic oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
First-attempt success rate
The primary study outcome is to evaluate the first attempt success rate of oral tracheal intubation without desaturation (< 90%) and/or bradycardia (< 100 bpm) with video laryngoscope with supplemental oxygen (apneic oxygenation) vs without supplemental oxygen in infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs
Measured: From randomization until up to 15 minutes
Secondary outcomes (9)
Desaturation rate
Occurrence and duration of moderate and severe desaturation (SpO2 < 90% and SpO2 < 80%), with or without bradycardia, during intubation.
Measured: From randomization until up to 15 minutes
Overall number of intubation attempts
The overall number of intubation attempts.
Measured: From randomization until up to 15 minutes
Time to intubation
Time required for intubation (in seconds, defined from the first introduction of laryngoscope between the lips till successful lung ventilation defined as positive capnography).
Measured: From randomization until up to 5 minutes
Respiratory complications rate
Respiratory complications and complications of airway management within the first 24 hours, such as airway injury, cardiopulmonary resuscitation, bleeding, aspiration of gastric contents, post-extubation stridor, laryngospasm, bronchospasm, need for High Flow Nasal Oxygen (if not preoperatively on oxygen), need for low flow nasal oxygen (if not preoperatively on oxygen) or need for re-intubation will be recorded. Respiratory complications are defined as the need for re-intubation after being extubated, persistent stridor (even if oxygen is not required), respiratory failure, the occurrence of pneumothorax, or the need for any additional diagnostic examination following respiratory problems (i.e., bronchoscopy, radiology).
Measured: From randomization until up to 24 hours
First EtCO2 after successful intubation
Value in mmHg or kPa of the first reliable etCO2 reading after successful intubation
Measured: From randomization until up to 10 minutes
Cormack-Lehane score
The Cormack-Lehane score, classified as 1, 2a, 2b, 3, or 4, recorded at each laryngoscopy attempt
Measured: From randomization until up to 5 minutes
The need for additional devices
The need for additional devices used at any step of intubation
Measured: From randomization until up to 5 minutes
Duration of severe desaturation
Duration of moderate and severe desaturation (SpO2 < 80%), with or without bradycardia, during intubation
Measured: From randomization until up to 15 minutes
Percentage of Glottic Opening (POGO) score
Percentage of Glottic Opening (POGO) score recorded at each laryngoscopy attempt, ranging from 0% to 100%, with 100% indicating the best possible glottic view
Measured: From randomization until up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Dec 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Difficult AirwayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vinícius C Quintão, MD, MSc, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern, The University of Western Australia
- Responsible party
- Sponsor-investigator, Vinícius C Quintão, MD, MSc, PhD, University of Sao Paulo General Hospital
- Investigators
- Vinicius C Quintao, MD, MSc, PhD, Principal investigator, Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06683599
- Sponsor's protocol ID
- SEALION
- Acronym
- SEALION
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 2024
- Last updated
- 25 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
PubMed 29715354Patel R, Lenczyk M, Hannallah RS, McGill WA. Age and the onset of desaturation in apnoeic children. Can J Anaesth. 1994 Sep;41(9):771-4. doi: 10.1007/BF03011582.
PubMed 7954992Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.
PubMed 16873387Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.
PubMed 7856895Shiima Y, Berg RA, Bogner HR, Morales KH, Nadkarni VM, Nishisaki A; National Emergency Airway Registry for Children Investigators. Cardiac Arrests Associated With Tracheal Intubations in PICUs: A Multicenter Cohort Study. Crit Care Med. 2016 Sep;44(9):1675-82. doi: 10.1097/CCM.0000000000001741.
PubMed 27071070Stinson HR, Srinivasan V, Topjian AA, Sutton RM, Nadkarni VM, Berg RA, Raymond TT; American Heart Association Get With the Guidelines-Resuscitation Investigators. Failure of Invasive Airway Placement on the First Attempt Is Associated With Progression to Cardiac Arrest in Pediatric Acute Respiratory Compromise. Pediatr Crit Care Med. 2018 Jan;19(1):9-16. doi: 10.1097/PCC.0000000000001370.
PubMed 29135805Nishisaki A, Ferry S, Colborn S, DeFalco C, Dominguez T, Brown CA 3rd, Helfaer MA, Berg RA, Walls RM, Nadkarni VM; National Emergency Airway Registry (NEAR); National Emergency Airway Registry for kids (NEAR4KIDS) Investigators. Characterization of tracheal intubation process of care and safety outcomes in a tertiary pediatric intensive care unit. Pediatr Crit Care Med. 2012 Jan;13(1):e5-10. doi: 10.1097/PCC.0b013e3181fe472d.
PubMed 21057359Khemani RG, Markovitz BP, Curley MAQ. Characteristics of children intubated and mechanically ventilated in 16 PICUs. Chest. 2009 Sep;136(3):765-771. doi: 10.1378/chest.09-0207. Epub 2009 Jun 19.
PubMed 19542258Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
PubMed 26705976Disma N, Virag K, Riva T, Kaufmann J, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. Br J Anaesth. 2021 Jun;126(6):1173-1181. doi: 10.1016/j.bja.2021.02.021. Epub 2021 Apr 1.
PubMed 33812665Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.
PubMed 35476651
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SEALion: a Study on the Effectiveness of Additional Oxygenation in Little Children During Intubation Using Oxygenation Delivered by Nasal Cannula
- ClinicalTrials.gov ID
- NCT06683599
- Acronym / sponsor ID
- SEALION / SEALION
- Conditions
- Difficult Airway, Difficult Airway Intubation, Neonate
- Keywords
- Difficult intubation, Apneic oxygenation, Neonate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Vinícius C Quintão, MD, MSc, PhDUniversity, hospital or other
- Collaborators
- University of Bern, The University of Western Australia
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tracheal intubation in neonates can be technically challenging, even for experienced pediatric anesthesiologists, with a high first-attempt success rate crucial to ensure safety. Intubation, while life-saving for children with circulatory shock or respiratory failure, carries risks of severe desaturation that can lead to hypoxic encephalopathy, cardiac arrest, or death. Neonates, especially, are prone to hypoxemia due to high oxygen consumption, low functional residual capacity, small closing capacity, and increased risk of airway collapse, which is exacerbated under anesthesia and neuromuscular paralysis. Rapid desaturation occurs after cessation of ventilation, with neonates facing shorter apnea times before desaturation. Studies show that about two-thirds of neonates undergoing non-emergency nasotracheal intubation experience desaturation (SpO₂ <80% for over 60 seconds), although low-flow oxygen supplementation (0.2 L/kg/min) can extend safe apnea time.
This study aims to investigate apneic oxygenation with VL (using Miller or Macintosh blades size 0 or 1) in operating rooms or intensive care units. We hypothesize that supplemental oxygen and standardized VL use will improve first-pass success rates and reduce adverse events.
Detailed description
Eligible children will undergo preparation for intubation following the local Standard Operating Procedures (SOPs) of the pediatric anesthesia departments. Mandatory monitoring includes pulse oximetry (SpO2), heart rate (HR), and non-invasive blood pressure (NIBP).
Anesthesia Induction:
Where feasible, all children enrolled in this protocol will be pre-oxygenated for one minute prior to induction of anesthesia using a face mask with FiO2 1.0 and a flow rate of 6-10 L/min. Anesthesia induction for tracheal intubation will involve a combination of sedative or hypnotic drugs, opioids, and a non-depolarizing muscle relaxant.
Required Medications (per protocol):
Neuromuscular Blocking Agent (NMBA): One of the following-Rocuronium 0.5-1 mg/kg, Cis-Atracurium 0.2-0.5 mg/kg, Atracurium 0.5 mg/kg, Vecuronium 0.1 mg/kg, Mivacurium 0.2-0.3 mg/kg, or Succinylcholine 2 mg/kg.
Hypnotic Agent: One or more of the following-Thiopentone 4-7 mg/kg, Ketamine 0.5-2 mg/kg, Propofol 1-4 mg/kg, Midazolam 0.5-1 mg/kg, or Sevoflurane up to 8%.
Optional Medications: An opioid and/or anticholinergic may be administered at the anesthetist's discretion.
Pre-Intubation Preparation:
Following induction of anesthesia and administration of an NMBA, bag-mask ventilation with FiO2 1.0 (flow rate of 6-10 L/min) will be performed for 60 seconds until apnea occurs. To facilitate airway management, complete neuromuscular blockade will be confirmed using train-of-four (TOF) monitoring. Oxygen administration, laryngoscopy, and tracheal intubation will follow.
Intubation Procedure:
Oxygen administration during intubation is mandatory for all participants and will be randomized as follows:
Apneic Oxygenation: Oxygen will be administered at 1 L/kg/min via a conventional nasal cannula. Laryngoscopy and tracheal intubation will proceed following apneic oxygenation.
Standard Care: No apneic oxygenation will be administered. After induction, laryngoscopy and tracheal intubation will proceed without additional oxygen support.
Tube Selection:
For premature neonates under 1 kg, an uncuffed tube with an internal diameter (ID) of 2.5 will be used.
For premature neonates and newborns between 1 kg and 3.0 kg, an uncuffed tube with ID 3.0 will be used.
For babies over 3.0 kg up to 8 months, a cuffed tube with ID 3.0 or an uncuffed tube with ID 3.5 will be used.
For infants aged 8 to 12 months, a cuffed tube with ID 3.5 or an uncuffed tube with ID 4.0 will be used.
Oxygen delivery will follow the assigned randomization group, either via conventional nasal cannula (apneic oxygenation) or standard care.
Laryngoscope Blade Selection:
For children weighing less than 1 kg, a Miller or Macintosh blade, size No. 0, will be used. In cases of unexpected difficult intubation, the difficult airway algorithm will be applied. After an unsuccessful first intubation attempt with the assigned flow rate, clinical judgment will guide the intubating physician on whether to repeat the attempt with the same flow rate or to modify the flow rate, blade size, or type of laryngoscope. A maximum of four intubation attempts will be allowed, with the final attempt performed by the most experienced physician present. Additional tools, such as a stylet or bougie, may be used at any stage. If intubation remains unsuccessful, the difficult airway algorithm will be applied, and a supraglottic airway (SGA) device will be inserted.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –Tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1 without apneic oxygenation. |
| Apneic oxygenation | Experimental | Procedure: Apneic oxygenation1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1. |
Who may qualify
- Ages
- 1 minute to 52 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric patients requiring oral or nasal tracheal intubation for elective, semi-elective, or urgent surgical and non-surgical procedures.
- Neonates and infants up to 52 weeks post-conceptual age.
- Written informed consent provided by legal guardians prior to the intervention.
Key exclusion criteria (3 listed)
- Prediction of difficult intubation based on physical examination or a history of previous difficult intubation.
- Requirement for an alternative technique to direct laryngoscopy to secure the airway.
- Specific conditions, such as congenital heart disease requiring FiO₂ < 1.0, or cardiopulmonary collapse necessitating advanced life support and intubation for emergency surgical or non-surgical interventions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apneic oxygenation1 L/kg/min FiO2 1.0 low-flow nasal supplemental oxygen with conventional nasal cannula during tracheal intubation performed with a video laryngoscope with Miller-blade or Macintosh-blade size No. 0 or No. 1. | Procedure or surgery | Apneic oxygenation |
Primary outcome
First-attempt success rate
Time frame: From randomization until up to 15 minutes
The primary study outcome is to evaluate the first attempt success rate of oral tracheal intubation without desaturation (< 90%) and/or bradycardia (< 100 bpm) with video laryngoscope with supplemental oxygen (apneic oxygenation) vs without supplemental oxygen in infants up to 52 weeks postconceptual age. A successful tracheal intubation (ETI) attempt is defined as successful placement of a tracheal tube in the trachea, confirmed by visualization of the tube passing the vocal cords, a waveform capnography suggesting correct ETT placement and auscultation of breath sounds in the lungs
9 secondary outcomes
Desaturation rate
Time frame: From randomization until up to 15 minutes
Overall number of intubation attempts
Time frame: From randomization until up to 15 minutes
Time to intubation
Time frame: From randomization until up to 5 minutes
Respiratory complications rate
Time frame: From randomization until up to 24 hours
First EtCO2 after successful intubation
Time frame: From randomization until up to 10 minutes
Cormack-Lehane score
Time frame: From randomization until up to 5 minutes
The need for additional devices
Time frame: From randomization until up to 5 minutes
Duration of severe desaturation
Time frame: From randomization until up to 15 minutes
Percentage of Glottic Opening (POGO) score
Time frame: From randomization until up to 5 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Background: PubMed 29715354Durrmeyer X, Breinig S, Claris O, Tourneux P, Alexandre C, Saliba E, Beuchee A, Jung C, Levy C, Marchand-Martin L, Marcoux MO, Dechartres A, Danan C; PRETTINEO Research Group. Effect of Atropine With Propofol vs Atropine With Atracurium and Sufentanil on Oxygen Desaturation in Neonates Requiring Nonemergency Intubation: A Randomized Clinical Trial. JAMA. 2018 May 1;319(17):1790-1801. doi: 10.1001/jama.2018.3708.
- Background: PubMed 7954992Patel R, Lenczyk M, Hannallah RS, McGill WA. Age and the onset of desaturation in apnoeic children. Can J Anaesth. 1994 Sep;41(9):771-4. doi: 10.1007/BF03011582.
- Background: PubMed 16873387Hardman JG, Wills JS. The development of hypoxaemia during apnoea in children: a computational modelling investigation. Br J Anaesth. 2006 Oct;97(4):564-70. doi: 10.1093/bja/ael178. Epub 2006 Jul 27.
- Background: PubMed 7856895Schwartz DE, Matthay MA, Cohen NH. Death and other complications of emergency airway management in critically ill adults. A prospective investigation of 297 tracheal intubations. Anesthesiology. 1995 Feb;82(2):367-76. doi: 10.1097/00000542-199502000-00007.
- Background: PubMed 27071070Shiima Y, Berg RA, Bogner HR, Morales KH, Nadkarni VM, Nishisaki A; National Emergency Airway Registry for Children Investigators. Cardiac Arrests Associated With Tracheal Intubations in PICUs: A Multicenter Cohort Study. Crit Care Med. 2016 Sep;44(9):1675-82. doi: 10.1097/CCM.0000000000001741.
- Background: PubMed 29135805Stinson HR, Srinivasan V, Topjian AA, Sutton RM, Nadkarni VM, Berg RA, Raymond TT; American Heart Association Get With the Guidelines-Resuscitation Investigators. Failure of Invasive Airway Placement on the First Attempt Is Associated With Progression to Cardiac Arrest in Pediatric Acute Respiratory Compromise. Pediatr Crit Care Med. 2018 Jan;19(1):9-16. doi: 10.1097/PCC.0000000000001370.
- Background: PubMed 21057359Nishisaki A, Ferry S, Colborn S, DeFalco C, Dominguez T, Brown CA 3rd, Helfaer MA, Berg RA, Walls RM, Nadkarni VM; National Emergency Airway Registry (NEAR); National Emergency Airway Registry for kids (NEAR4KIDS) Investigators. Characterization of tracheal intubation process of care and safety outcomes in a tertiary pediatric intensive care unit. Pediatr Crit Care Med. 2012 Jan;13(1):e5-10. doi: 10.1097/PCC.0b013e3181fe472d.
- Background: PubMed 19542258Khemani RG, Markovitz BP, Curley MAQ. Characteristics of children intubated and mechanically ventilated in 16 PICUs. Chest. 2009 Sep;136(3):765-771. doi: 10.1378/chest.09-0207. Epub 2009 Jun 19.
- Background: PubMed 26705976Fiadjoe JE, Nishisaki A, Jagannathan N, Hunyady AI, Greenberg RS, Reynolds PI, Matuszczak ME, Rehman MA, Polaner DM, Szmuk P, Nadkarni VM, McGowan FX Jr, Litman RS, Kovatsis PG. Airway management complications in children with difficult tracheal intubation from the Pediatric Difficult Intubation (PeDI) registry: a prospective cohort analysis. Lancet Respir Med. 2016 Jan;4(1):37-48. doi: 10.1016/S2213-2600(15)00508-1. Epub 2015 Dec 17.
- Background: PubMed 33812665Disma N, Virag K, Riva T, Kaufmann J, Engelhardt T, Habre W; NECTARINE Group of the European Society of Anaesthesiology Clinical Trial Network; AUSTRIA (Maria Vittinghoff); BELGIUM (Francis Veyckemans); CROATIA (Sandra Kralik); CZECH REPUBLIC (Jiri Zurek); DENMARK (Tom Hansen); ESTONIA (Reet Kikas); FINLAND (Tuula Manner); FRANCE (Christophe Dadure, Anne Lafargue); GERMANY (Karin Becke, Claudia Hoehne); GREECE (Anna Malisiova); HUNGARY (Andrea Szekely); IRELAND (Brendan O'Hare); ITALY (Nicola Disma); LATVIA (Zane Straume); LITHUANIA (Laura Lukosiene); LUXEMBOURG (Bernd Schmitz); MALTA (Francis Borg); NETHERLANDS (Jurgen de Graaff); NORWAY (Wenche B Boerke); POLAND (Marzena Zielinska); PORTUGAL (Maria Domingas Patuleia); ROMANIA (Radu Tabacaru); SERBIA (Dusica Simic); SLOVAKIA (Miloslav Hanula); SLOVENIA (Jelena Berger); SPAIN (Ignacio Galvez Escalera); SWEDEN (Albert Castellheim); SWITZERLAND (Walid Habre); TURKEY (Dilek Ozcengiz - Zehra Hatipoglu); UKRAINE (Dmytro Dmytriiev); UNITED KINGDOM (Thomas Engelhardt, Suellen Walker); Management Team. Difficult tracheal intubation in neonates and infants. NEonate and Children audiT of Anaesthesia pRactice IN Europe (NECTARINE): a prospective European multicentre observational study. Br J Anaesth. 2021 Jun;126(6):1173-1181. doi: 10.1016/j.bja.2021.02.021. Epub 2021 Apr 1.
- Background: PubMed 35476651Hodgson KA, Owen LS, Kamlin COF, Roberts CT, Newman SE, Francis KL, Donath SM, Davis PG, Manley BJ. Nasal High-Flow Therapy during Neonatal Endotracheal Intubation. N Engl J Med. 2022 Apr 28;386(17):1627-1637. doi: 10.1056/NEJMoa2116735.
- Individual participant dataSharing planned: No
Related trials for Difficult Airway
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Enrolling by invitation
Pediatric Intubation Simulations With Bougie
Difficult Airway Intubation
Not yet recruiting
Title of Study: Anesthesiologists' Learning Curves for Ultrasound Assessment of Difficult Airway
Airway Ultrasound, Difficult Airway Management
RecruitingObservational study
Airway Ultrasound in Oncologic Maxillofacial Patients
Head and Neck Cancer
Not yet recruitingObservational study
Sniffing Position vs Left Head Rotation (LeHeR) Maneuver for Glottic View During Direct Laryngoscopy
Difficult Intubation, Laryngoscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Vinicius C Quintao, MD, MSc, PhD principal investigator
Hospital das Clinicas, Faculdade de Medicina, Universidade de Sao Paulo
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Apneic oxygenation in people with Difficult Airway and Difficult Airway Intubation, run by Vinícius C Quintão, MD, MSc, PhD at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia, Brazil, Canada, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vinicius C Quintao, MD, MSc, PhD (+ 55 11 97127-3950, vinicius.quintao@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First-attempt success rate (time frame: From randomization until up to 15 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06683599, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.